BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 383304 · Received March 14, 2002

    Report

    Report Number
    1423500-2002-00332
    Event Type
    Malfunction
    Date Received
    March 14, 2002
    Date of Event
    March 7, 2002
    Report Date
    March 7, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) FOR ASSISTANCE DURING APD THERAPY. HP REPORTED THE SUPPLY LINE SPIKE HAD SEPARATED FROM THE SOLUTION BAG. TECH ASSITED HP IN DISCONTINUING THERAPY AND RESUMING WITH NEW SET UP. HP REPORTS THERAPY WAS COMPLETED WITHOUT INCIDENT AND REPORTED NO PT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT.